WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Pristiq or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Pristiq is not approved for use in pediatric patients [ see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 ), and Patient Counseling Information ( 17.1 ) ].
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PRISTIQ SUMMARY
Pristiq is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O‑desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive, generalized anxiety, social anxiety and panic disorders.
Pristiq, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [ see Clinical Studies (14) and Dosage and Administration (2.1) ]. The efficacy of Pristiq has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder.
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
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PRISTIQ NEWS HIGHLIGHTS Media Articles Related to Pristiq (Desvenlafaxine)
Depression leads to internal fat in 70-somethings (AP)
Source: Y! Health Depression News [2008.12.01]
Cognitive Behavioural Therapy (CBT) 'Works Best With Recurrent Depression'
Source: Depression News From Medical News Today [2008.11.30]
Treating depression seen important in heart failure (Reuters)
Source: Y! Health Depression News [2008.11.28]
Depression May Up Heart Attack Risk
Source: MedicineNet Congestive Heart Failure Specialty [2008.11.26]
Seniors Who Experienced The Great Depression Facing Growing Anxiety Today
Source: Anxiety / Stress News From Medical News Today [2008.11.25]
Published Studies Related to Pristiq (Desvenlafaxine)
Efficacy, safety, and tolerability of fixed-dose desvenlafaxine 50 and 100 mg/day for major depressive disorder in a placebo-controlled trial. [2008.09]
Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms: a randomized controlled trial. [2008.01]
A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in adult outpatients with major depressive disorder. [2007.11]
A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder. [2007.11]
A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. [2007.05]
Clinical Trials Related to Pristiq (Desvenlafaxine)
Study Evaluating the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Menopausal Women [Recruiting]
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients With Major Depressive Disorder [Recruiting]
Study Evaluating DVS SR in the Treatment of Child and Adolescent Outpatients With Major Depressive Disorder [Recruiting]
A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia [Recruiting]
Paroxetine-Referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD [Recruiting]
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